MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK MS INSTRUMENT; VITEK® MS INSTRUMENT

Model Number 410895R

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from italy notified biomérieux of obtaining misidentification results in association with the vitek® ms instrument (ref.410895, serial (b)(4)) for an unspecified amount of patient and quality control samples.The customer specifically stated the vitek® ms misidentified a qc strain of enterococcus faecium as enterococcus brucella.Following calibration of the vitek® ms instrument, the customer confirmed the issue was resolved.The customer confirmed the correct identification results were provided to the treating physician, and that the discrepant identification results had no adverse impact to any patient¿s state of health.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in italy regarding misidentification results in association with the vitek® ms instrument (ref.(b)(4), serial (b)(6)) for an unspecified amount of patient and quality control samples.*fine tuning: analyzed data showed the status was not good at the time of acquisition.A fine tuning was needed during the customer's testing.*spot preparation quality: the calibrator spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.*sample data analysis: reprocessing of the customer data with vitek ms kb v3.2 allows to show that the low discrimination identification was obtained with low scores and low number of peaks that were close to the acceptable limits for giving an ¿identification¿ result, or a ¿no identification¿ result.A low discrimination result is not the final identification as written in the vitek ms knowledge base user manual clinical use v3.2 - ref.(b)(4).Additional laboratory tests as determined by microbiology laboratory protocols for low discrimination results are necessary for the completion of the organism identification.The expected identification after the investigation is unknown.The identification has to be confirmed with a reference method (sequencing).*root cause: fine tuning has drifted under the vilink alert tool criteria.Non optimal spot preparation.See section h10.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10089713
• MDR Text Key: 228605725
• Report Number: 9615754-2020-00082
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• PMA/PMN Number: DEN130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410895R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1